CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that additional preliminary data from its Phase 2b clinical trial demonstrating aldoxorubicin’s potential advantage over doxorubicin in the treatment of soft tissue sarcoma (STS) will be presented at the 18 th Annual Connective Tissue Oncology Society (CTOS) Meeting on Thursday, October 31 at 4:30 p.m. Eastern time at the Sheraton New York Times Square Hotel. The Company previously reported that patients in the trial treated with aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those administered the widely used chemotherapeutic agent doxorubicin had an ORR of 0%. The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013. “Because CTOS draws thought leaders in the treatment of sarcoma from around the world, it provides an ideal forum to gain awareness of this compelling data and to acquaint the oncologists with our phase 3 study in patients with relapsed or refractory soft tissue sarcomas,” said CytRx President and CEO Steven A. Kriegsman. "Discoveries of new sarcoma treatments have been relatively few, particularly when compared with treatments for breast or prostate cancer, but the preliminary clinical results thus far drive our optimism that aldoxorubicin can fill an important medical need in patients with advanced soft tissue sarcoma. ” STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. There are more than 30 types of STS, and according to the American Cancer Society more than 10,500 new cases are diagnosed each year in the U.S. In addition to the Phase 2b trial for STS, the Company has received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a difficult-to-treat and deadly brain cancer, and also plans to conduct a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma.
About AldoxorubicinThe widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m 2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m 2. About the Connective Tissue Oncology Society Formed in 1995 and incorporated in 1997, the Connective Tissue Oncology Society (CTOS) is an international group comprised of physicians and scientists with a primary interest in the tumors of connective tissues. The goal of the society is to advance the care of patients with connective tissue tumors and to increase knowledge of all aspects of the biology of these tumors, including basic and clinical research. About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also is initiating Phase 2 clinical trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx's clinical trials, the risk that any future human testing of aldoxorubicin, including the conclusion of the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response results similar to the preliminary data described in this press release, or might not correlate with the trial’s primary endpoint of progression-free survival, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.